Pharmacokinetic Solidarity? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-04-02 13:00  – Posting: # 20113
Views: 624

Furthermore, the EMA is considering the FDA’s definition as laid down in CFR21§320.23(a)(1) for locally acting drugs

[…] scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
(my emphasis)

and will require biopsies as of April 1st, 2022.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,687 posts in 4,178 threads, 1,352 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 20:27 CEST

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5